The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation

Fluid Responsiveness Clinical Trial

Official title:

The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01113073
• Other study ID #: UMCN_IC_BL_01/2010
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2010
• Last updated: August 30, 2010
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: January 2010
• Source: Radboud University
• Contact: Peter Pickkers, MD, PhD
• Email: p.pickkers[@]ic.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

Fluid administration is a daily intervention on the intensive care unit to improve cardiac output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume status of the patient is very difficult to assess. Too little volume leads to inadequate organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart failure and cause pulmonary and peripheral edema and contribute to further tissue injury and organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of fluid responsiveness, this relevant and complex task is usually guided by static clinical variables and the specialist's interpretation due to the fact that the interpretation of dynamic parameters is not fully developed and that they are not universally available. This lack of understanding is partially because of the complex interaction with mechanical ventilation. The investigators hypothesize that knowing the distribution of ventilatory pressures will make it possible to index dynamic parameters to tidal volume and improve their predictive value concerning the volume status of the patient. In addition, it would be of interest to be able to predict fluid responsiveness in a non-invasive way, especially in critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using Nexfin in critically ill patients has not been validated and also not tested for its ability to predict fluid responsiveness. The present research proposal evaluates the possibility and accuracy of the model flow analysis obtained by non-invasive finger arterial pressure measurements to determine fluid responsiveness using passive leg raising. It will also be compared to a more invasive method (that is currently used in the clinic) to assess its ability to measure absolute CO levels accurately. It may make it possible to assess fluid responsiveness in a non-invasive and patient friendly way.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Elective open heart surgery.

Exclusion Criteria:

• Significant cardiac arrhythmias, including atrial fibrillation.

• Hemodynamical instability, as defined by a variation in heart rate, blood pressure and cardiac output of more than 10% during the 15-min period before starting the protocol.

• Recent myocardial infarction (< 3 mnd, troponine > 50 ug/l).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fluid Responsiveness

Intervention

Other:
• ventilatory protocol
Ventilatory protocol for short period with four different tidal volumes (12 min)
• Elastic band
Placement of an elastic band around thorax to reduce thorax compliance
• passive leg raising test
performing the passive leg raising test

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid responsiveness	pulse pressure variation (PPV), systolic pressure variation (SPV), stroke volume variation (SVV), pre-ejection period variation (dPEP)	30 minutes around fluid challenge	No
Secondary	Pressure distribution in thorax due to mechanical ventilation	mechanical ventilation with 4 different tidal volumes and decreased chest compliance	30 minutes of varying tidal volumes	No
Secondary	Dynamic indices in pressure support ventilation		30 minutes of pressure support	No
Secondary	non invasive prediction of fluid responsiveness	pulse contour analysis of cardiac output with finger cuff combined with passive leg raising test	30 minutes around fluid challenge	No
Secondary	pressure distribution and dynamic indices during spontaneous breathing		5 minutes of spontaneous breathing	No